Method for deactivating and maintaining items in a deactivated state

ABSTRACT

A method of microbially deactivating items and storing the same, comprising the steps of:
         a) placing items within a cavity in a sealable container having fluid access ports therein, the fluid access ports having a normally closed position and being moveable to an open position;   b) placing the container having items to be microbially deactivated in the cavity into a reprocessor having a circulation system for circulating a microbial deactivation fluid during a deactivation cycle, wherein the fluid access ports in the container are moved to the open position to be in fluid communication with the circulation systems by contact with the reprocessor;   c) circulating the microbial deactivation fluid through the cavity of the container; and   d) removing the container from the reprocessor following a deactivation cycle, wherein removal of the container from the reprocessor causes the fluid access ports to assume the normally closed position.

FIELD OF THE INVENTION

The present invention relates to disinfection or deactivation ofmedical, dental, pharmaceutical, veterinary or mortuary instruments anddevices, and more particularly to a method and apparatus fordeactivating items and for maintaining the items in a deactivated state.

BACKGROUND OF THE INVENTION

Medical, dental, pharmaceutical, veterinary or mortuary instruments anddevices that are exposed to blood or other body fluids require thoroughcleaning and anti-microbial deactivation between each use. Liquidmicrobial deactivation systems are now widely used to clean anddeactivate instruments and devices that cannot withstand the hightemperatures of a steam deactivation system. Liquid microbialdeactivation systems typically operate by exposing the medical devicesand/or instruments to a liquid disinfectant or deactivation composition,such as peracetic acid or some other strong oxidant.

In such systems, the instruments or devices to be cleaned are typicallyplaced within a deactivation chamber within the liquid microbialdeactivation system, or in a container that is placed within thedeactivation chamber. During a deactivation cycle, a liquid disinfectantis then circulated through a liquid circulation system that includes thedeactivation chamber (and the container therein).

Following a deactivation cycle in a conventional reprocessor, thedeactivated items are manually removed from the reprocessor, or from atray or container that holds the items in the reprocessor during thedeactivation cycle. The deactivated items are typically transferred to astorage cassette, or are sealed in a protective anti-microbial wrap toprevent deactivation of the items once they (the items) have beenremoved from the reprocessor. However, no matter how carefully the itemsare removed from the reprocessor, the items are exposed to airbornebio-contaminants once the items are exposed to the surroundingatmosphere. Thus, if the items are stored for a prolonged period of timebefore their next use in an operating room or the like, thebio-contaminants have time to populate within the storage cassette oranti-microbial wrap.

The present invention overcomes these and other problems and provides amethod and apparatus for deactivating items, and a device for storingsuch deactivated items.

SUMMARY OF THE INVENTION

In accordance with a preferred embodiment of the present invention,there is provided a method of microbially deactivating items and storingthe same, comprising the steps of:

a) placing items within a cavity in a sealable container having fluidaccess ports therein, the fluid access ports having a normally closedposition and being moveable to an open position;

b) placing the container having items to be microbially deactivated inthe cavity into a reprocessor having a circulation system forcirculating a microbial deactivation fluid during a deactivation cycle,wherein the fluid access ports in the container are moved to the openposition by actuating means on the reprocessor to be in fluidcommunication with the circulation systems;

c) circulating the microbial deactivation fluid through the cavity ofthe container; and

d) removing the container from the reprocessor following a deactivationcycle, wherein removal of the container from the reprocessor causes thefluid access ports to assume the normally closed position.

In accordance with another aspect of the present invention, there isprovided a method of microbially deactivating items and storing thesame, comprising the steps of:

a) placing items to be deactivated into a cavity in a sealable containerhaving a controllable fluid access port therein to allow fluid accessinto the cavity;

b) placing the container having items to be deactivated therein into areprocessor having a circulation system for circulating a microbialdeactivation fluid through the cavity;

c) circulating the microbial deactivation fluid through the cavity;

d) removing the container following a deactivation cycle; and

e) storing the container with the deactivated items therein.

One advantage of the present invention is the provision of an apparatusfor deactivating medical instruments and items.

Another advantage of the present invention is the provision of acontainer for holding medical instruments and items during a microbialdeactivation process, which container maintains the instruments in adeactivated environment therein for a prolonged period of time afterremoval of the container from the apparatus.

A still further advantage of the present invention is a container asdescribed above that may be used as a storage device for storing themicrobially deactivated instruments until use.

These and other advantages will become apparent from the followingdescription of a preferred embodiment taken together with theaccompanying drawings and the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention may take physical form in certain parts and arrangement ofparts, a preferred embodiment of which will be described in detail inthe specification and illustrated in the accompanying drawings whichform a part hereof, and wherein:

FIG. 1 is a perspective view of an upper portion of an automatedreprocessor for microbially deactivating instruments and devices,according to the present invention;

FIG. 2 is a schematic-diagram of the reprocessor shown in FIG. 1;

FIG. 3 is an exploded view of a container for holding items to bemicrobially deactivated in the reprocessor shown in FIG. 1;

FIG. 4 is a sectional view taken along lines 4-4 of FIG. 1;

FIG. 5 is a sectional view taken along lines 5-5 of FIG. 1;

FIG. 6 is a top plan view of the container, showing a portion of a lidbroken away;

FIG. 7 is an enlarged, bottom plan view of a portion of the container;

FIG. 8 is an enlarged view of the identified area shown in FIG. 4;

FIG. 9 is an enlarged view of the identified area shown in FIG. 4;

FIG. 10 is an enlarged view of a portion of the lid and container,showing a locking arrangement in a locked configuration;

FIG. 11 is an enlarged view of the lid and container portions shown inFIG. 10, showing a locking arrangement in an opened configuration;

FIG. 12 is an enlarged view showing an outlet valve of the containerspaced-apart from a male outlet connector on the reprocessor housing;

FIG. 13 is an enlarged, sectional view showing the outlet valve of thecontainer in operative engagement with the male connector on thereprocessor housing;

FIG. 14 is a perspective view of a rack assembly for holding items to bedeactivated, showing medical instruments mounted thereon;

FIG. 15 is perspective view of a base section of the tray assembly shownin FIG. 14, showing mounting blocks exploded therefrom;

FIG. 16 is an enlarged, elevational view of a mounting block assemblyfor holding portions of the items to be microbially deactivated;

FIG. 17 is a perspective view of an upper section of the tray assemblyshown in FIG. 14;

FIG. 18 is a top plan view showing a medical instrument within thecontainer, and illustrating a flush tube connected to the medicalinstrument;

FIG. 19 is an enlarged, perspective view showing a connector on one endof the lumen flush tube, illustrating a connector assembly for attachingthe lumen flush tube to the container;

FIG. 20 is a sectional view showing a connector assembly for connectingthe lumen flush tubes to a fitting on the instrument showing an internalvalve arrangement on the fitting;

FIG. 21 is a sectional view taken along lines 21-21 of FIG. 20;

FIG. 22 is a sectional view of the fitting shown in FIG. 20 attached toa portion of a medical instrument; and

FIG. 23 is a top plan view of a container according to the presentinvention and a monitoring system that is schematically illustratedtherewith.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENT

Referring now to the drawings wherein the showings are for the purposeof illustrating a preferred embodiment of the invention only, and notfor the purpose of limiting same, FIG. 1 shows an upper portion of anapparatus 10 for microbially deactivating medical instruments and otherdevices, illustrating a preferred embodiment of the present invention.

Apparatus 10 includes a housing structure 12 having an upper panel 14that defines a recess or cavity 16. Cavity 16 is dimensioned to receivea container 200. Container 200 is provided to receive the devices orinstruments to be deactivated. Container 200 is dimensioned to bereceived within recess or cavity 16, as illustrated in FIG. 1. A well 32(schematically illustrated in FIG. 2) is formed adjacent cavity 16. Well32 is dimensioned to receive a chemical delivery container 34 thatcontains dry chemical reagents that, when combined with water, form themicrobial deactivation fluid used in apparatus 10.

A manually operable lid 42 is movable between an opened position (shownin FIG. 1) allowing access to cavity 16, and a closed position (shown inFIG. 2) closing or covering cavity 16. A seal element 44 surroundscavity 16 and forms a fluid-tight seal between lid 42 and panel 14 whenlid 42 is in a closed position. Latch means (not shown) are provided forlatching and securing lid 42 in a closed position during a deactivationcycle. Cavity 16 essentially defines a deactivation chamber 50 when lid42 is in a closed position.

FIG. 2 shows a simplified, schematic piping diagram of apparatus 10. Afluid circulation system 60 provides the microbial deactivation fluid todeactivation chamber 50 and is further operable to circulate themicrobial deactivation fluid through deactivation chamber 50 andcontainer 200. Fluid circulation system 60 includes a water inlet line62 that is connected to a source of heated water (not shown). A pair ofmacro filters 64, 66 are provided in water inlet line 62 to filter largecontaminants that may exist in the incoming water. An ultraviolet (UV)treatment device 68 for deactivating organisms within the water sourceis preferably provided in inlet line 62. A water valve 72 controls theflow of water from water inlet line 62 to a system feeder line 82.System feeder line 82 includes two filter elements 84, 86 in series tofilter microscopic organisms from the incoming water so as to providesterile water to fluid circulation system 60. A heating element 88 isdisposed in system feeder line 82 downstream from filter elements 84,86. System feeder line 82 splits into a first branch feeder line 92 anda second branch feeder line 94. First and second branch feeder lines 92,94 communicate with container 200 within deactivation chamber 50. Firstand second branch feeder lines 92, 94 are connected to container 200through fluid inlet assemblies 340, 360, schematically illustrated inFIG. 2. Fluid inlet assemblies 340, 360 are adapted to operativelyinteract with valve actuating connectors 410, mounted to panel 14, asshall be described in greater detail below. A third branch feeder line96 is connected to deactivation chamber 50 itself.

A supplemental branch feeder line 98 splits off of second branch feederline 94 and is directed to an inlet portion of chemical deliverycontainer 34 that contains dry chemical reagents that form the microbialdeactivation fluid used in apparatus 10. A valve 102 controls the flowthrough supplemental branch feeder line 98 to chemical deliverycontainer 34 and through line 94 connected to container 200. Flowrestrictors 74 are provided in third branch feeder line 96 andsupplemental branch feeder line 98 to limit flow therethrough. Chemicaldelivery container 34 is disposed within well 32 formed within panel 14of housing structure 12.

A branch return line 104 extends from chemical delivery container 34 andis connected to system return line 112. Likewise, branch fluid returnlines 106, 108 extend from container 200 and deactivation chamber 50,respectively, and are connected to system return line 112. A fluidoutlet assembly 280 on container 200 connects with branch return line106 via a valve actuating connector 410 on panel 14, as shall bedescribed in greater detail below.

System return line 112 connects back with water inlet line 62 and fluidfeeder line 82, as illustrated in FIG. 2. A pump 116 is disposed withinsystem return line 112. Pump 116 is operable to circulate fluid, i.e.,water and the microbial deactivation fluid, through fluid circulationsystem 60. A drain line 118 is connected to system return line 112. Adrain valve 122 controls fluid flow through drain line 118. Adirectional check valve 124 is disposed in system feeder line 82 betweenwater inlet line 62 and pump 116. A filter bypass line 76 communicateswith fluid system feeder line 82 on opposite sides of filters 84, 86.Specifically, one end of bypass line 76 is connected to system feederline 82 between pump 116 and directional check valve 124. The other endof bypass line 76 communicates with system feeder line 82 beyond filters84, 86 and heating device 88, but before where first, second and thirdbranch feeder lines 92, 94 and 96 are formed. A flow restrictor 78 isprovided in filter bypass line 76 to limit flow therethrough.

A system microprocessor or microcontroller (not shown) controls theoperation of the circulation system, as shall be described in greaterdetail below. The operation of the circulation system includes a fillphase, a circulation phase and a drain phase, as shall also be describedin greater detail below. To facilitate operation of the fill phase,circulation phase and drain phase, an air inlet/fluid overflow assembly132 is provided at the uppermost portion of deactivation chamber 50 influid communication therewith. Air inlet/fluid overflow assembly 132includes an overflow drain 134 to allow excess fluid within deactivationchamber 50 and circulation system 60 to overflow into a drain, and anair inlet to provide air into deactivation chamber 50 to facilitatedraining thereof. A filter 136 is provided in the air inlet to filterthe incoming air.

Referring now to FIGS. 3-7, container 200 is best seen. Container 200 isgenerally comprised of a tray 202 and a lid 550 that is attachablethereto. Tray 202 is generally cup-shaped and has a bottom wall 204 anda continuous side wall 206 that extends about the periphery of bottomwall 204, and that extends to one side thereof. Bottom wall 204 and sidewall 206 define a cavity 208 in which instruments or other items to bedeactivated are to be inserted. In the embodiment shown, tray 202 isgenerally oval in shape, although other shapes are contemplated withinthe scope of the present invention.

The upper edge of side wall 206, best seen in FIGS. 8 and 9, is shapedto define a portion of a seal element. In the embodiment shown, theupper edge of side wall 206 is formed to have two, spaced-apart rails212, 214 that extend continuously along the upper edge of side wall 206.Rails 212, 214 define a channel 216, best seen in FIG. 11 that likewiseextends continuously about the upper edge of side wall 206. Rails 212,214 on tray 202 are dimensioned to operatively engage correspondingelements on lid 550, as shall be described in greater detail below.

The bottom wall has an upper surface, designated 204 a in the drawings.Two spaced-apart, generally concave mounting pads 222, 224 extend fromupper surface 204 a of bottom wall 204. Each mounting pad 222, 224includes an arcuate-shaped slot or recess 226 formed therein. Mountingpad 222 has a recess or relief 232 formed therein. A pair ofspaced-apart connector fittings 234, 236 is mounted within recess orrelief 232 of mounting pad 222. Upper surface 204 a of bottom wall 204is generally contoured and includes a plurality of recesses 242, 244,246 and 248 that are dimensioned to receive and support portions of theinstruments or items to be microbially deactivated so as to facilitatepositioning such instruments or items within cavity 208 of tray 202. Tworecesses 252, 254 are formed between mounting pads 222, 224 at the endsthereof. Recesses 252, 254 include directional spray nozzles 256, 258.

In the embodiment shown, three fluid assemblies 280, 340, 360, two inletfluid assemblies 340, 360 and one fluid outlet assembly 280, are formedin tray 202 to allow a microbial deactivation fluid to flow into,through and out of container 200. Basically, first fluid inlet assembly340 facilitates flow of a microbial deactivation fluid into tray 202through nozzles 256, 258 and to the upper edge of side wall 206, asshall be described in greater detail below.

Second fluid inlet assembly 360 facilitates fluid flow to connectorfittings 234, 236 within recess 232 in mounting pad 222. Connectorfittings 234, 236 in turn are connectable to certain medical devices andinstruments by flexible connectors 712 (best seen in FIGS. 18 and 19) todirect the microbial deactivation fluid through lumens and passages insuch instruments.

Outlet fluid assembly 280 is provided to allow fluid to be drained fromcontainer 200.

Each of the aforementioned fluid assemblies 280, 340, 360 is comprisedof many like elements. A general understanding of three fluid assembliescan be realized with reference to FIG. 12, wherein fluid outlet assembly280 on tray 202 is best seen. A drain opening 292 is formed in bottomwall 204 of tray 202 near side wall 206. Drain opening 292 is preferablylocated at what will be the lowest point in container 200 when container200 is within deactivation chamber 50. An enlarged counter-sunk opening294 is formed in the bottom surface of bottom wall 204 to receive amounting plate 296. Mounting plate 296 is cylindrical in shape and has acylindrical body portion 296 a dimensioned to fit within counter-sunkopening 294 in tray 202. A cylindrical, tubular sleeve 296 b extendsdownwardly from mounting plate 296. Sleeve 296 b defines a cylindricalopening 302 that extends into a generally cup-shaped cavity formed inbody portion 296 a of mounting plate 296. An open grill or lattice-likestructure 304 is disposed within cylindrical opening 302 defined bytubular sleeve 296 b, as best seen in FIG. 7. A flexible valve element312 is mounted to tray 202 by mounting plate 296.

Valve element 312 includes a cylindrical central body portion 312 a thatis connected to an outer, annular, flanged ring portion 312 b by aplurality of radially extending arm portions 312 c that define opening312 d. Valve element 312 is preferably formed of a resilient, flexiblepolymeric material and is preferably molded as an integral piece. Acylindrical recess is formed in the bottom of central body portion 312 ato receive a rounded or domed cap element 314 formed of a hard, tough,durable polymeric material. Cap 314 is secured to central body portion312 a of valve element 312 by a conventional fastener 316, asillustrated in FIG. 12. Flanged ring portion 312 b of valve element 312is dimensioned to be captured by a recess in mounting plate 296.Mounting plate 296 is attached to tray 202 within counter-sunk opening294 by conventional fasteners 322.

Valve element 312 is molded or otherwise formed to assume a first,normal position, as shown in FIG. 12, wherein central body portion 312 aof valve element 312 engages or “seats” itself against the inner edge ofmounting plate 296 that surrounds cylindrical bore 302, therebyeffectively closing the opening through bottom wall 204 of tray 202.Valve element 312 is moveable to a second position, as best seen in FIG.13, wherein central body portion 312 a of valve element 312 is movedaway from mounting plate 296 to an opened position, and wherein acontinuous fluid passage is formed through drain opening 292, throughopenings 312 d between arms 312 c of valve element 312 and throughsleeve portion 296 b of mounting plate 296.

Referring now to FIGS. 5 and 7, first and second fluid inlet assemblies340, 360 are best seen. In the embodiment shown, fluid inlet assemblies340, 360 are disposed within a relatively large cavity or depression 322formed in the bottom wall of tray 202. Cavity 322 includes a large area322 a that is generally centrally located on the bottom surface of tray202 and a portion 322 b that extends to one side of tray 202. The bottomof cavity 322 is defined by a generally planar surface. First and secondpassage-defining cavities 334, 336 (best seen in phantom in FIG. 7) areformed in the planar surface that defines recess 322. Firstpassage-defining cavity 334 is generally V-shaped, and has a circularportion 334 a and two outwardly extending arm portions 334 b. Armportions 334 b of first passage-defining cavity 334 communicate withnozzles 256, 258 on the opposite side of bottom wall 204, as best seenin FIG. 5.

Second passage-defining cavity 336 has a large, circular portion 336 athat communicates with two, smaller circular portions 336 b that aretangent thereto. Two smaller circular portions 336 b of secondpassage-defining cavity 336 communicate with connector fittings 234, 236that are disposed within recess or relief 232 in mounting pad 222 on theopposite side of bottom wall 204.

A mounting plate 342, best seen in FIG. 3, is dimensioned to be attachedto bottom wall 204 of tray 202 and cover first passage-defining cavity334. In this respect, mounting plate 342 is generally V-shaped and haselongated arms 342 b to cover arm portions 334 b of firstpassage-defining cavity 334. Mounting plate 342 is generally flat, witha downwardly extending sleeve 342 a (best seen in FIGS. 4 and 5).Mounting plate 342 is dimensioned to capture and mount valve element 312of the type heretofore described. In this respect, mounting plate 342 isattached to tray 202 within recess 322 by a plurality of conventionalfasteners 344. A sleeve 342 a extends from mounting plate 342, anddefines an opening that communicates with valve element 312 that isdisposed between mounting plate 342 and tray 202. Mounting plate 342covers the open side of first passage-defining cavity 334, and thusdefines a fluid passage (best seen in FIG. 5) that connects valveelement 312 (that is captured by mounting plate 342) to spray nozzles254, 256 on the other side of bottom wall 204. In the embodiment shown,an elongated U-shaped rail or key 346 is formed on the upper surfaces ofeach leg portion 342 b of mounting plate 342 to locate and lock mountingplate 342 in mating grooves formed within recess 322 of tray 202. Asbest seen in FIG. 7, a tube or hose 352 is attached at one end tomounting plate 342 to communicate with the fluid passage defined bymounting plate 342 and fluid-defining cavity 334 within tray 202. Theother end of tube or hose 352 is connected to a channel 354 (best seenin FIGS. 4 and 8) that communicates with channel 216 along the upperedge of side wall 206.

Referring now to FIG. 3, second fluid inlet assembly 360 is best seen.Like first fluid inlet assembly 340, second fluid inlet assembly 360includes mounting plate 362, that is dimensioned to capture and holdvalve element 312 of the type heretofore described. Mounting plate 362of second fluid inlet assembly 360 is attached within extension portion322 b of recess 322 by conventional fasteners. Mounting plate 362 ispositioned to be in registry with, and to cover, second-passage definingcavity 336 within recess 322. Like mounting plate 342 in first inletassembly 340, mounting plate 362 of second fluid inlet assembly 360includes a key or rail 364 that extends about the periphery of mountingplate 362 to locate and lock mounting plate 362 into position in recess322 in bottom wall 204 of tray 202. Mounting plate 362 essentiallycovers second-passage defining cavity 336 to define a fluid passagebetween valve element 312 that is held by mounting plate 362 andopenings 366 that are connected to connector fittings 234, 236 on theopposite side of bottom wall 204.

In summary, outlet fluid assembly 280, and first and second inlet fluidassemblies 340, 360 each include like valve elements 312 that areoperatively mounted to the bottom of tray 202. Valve element 312 ofoutlet fluid assembly 280 communicates with branch return line 106.Valve element 312 of first fluid inlet assembly 340 connects branchfeeder line 92 with spray nozzles 256, 258 within cavity 208 of tray 202and with the upper edge of side wall 206. Valve element 312 of secondfluid inlet assembly 360 connects with connector fittings 234, 236 onmounting pad 222 within cavity 208 of tray 202. All of the valveelements 312 have a normally closed position that prevents flow of fluidtherethrough. As indicated above, valve elements 312 of theaforementioned fluid assemblies 280, 340, 360 are dimensioned tooperatively interact with a valve actuating connector 410 on panel 14 ofapparatus housing 12. In a preferred embodiment of the presentinvention, valve actuating connectors 410 for fluid assemblies 280, 340,360 are identical. Accordingly, only one valve actuating connector 410shall be described in detail, it being understood that such descriptionapplies equally to the other valve actuating connector 410.

Referring now to FIGS. 12 and 13, valve actuating connector 410associated with outlet fluid assembly 280 is best seen. In accordancewith one aspect of the present invention, valve actuating connector 410is mounted to panel 14 of housing 12 of apparatus 10 to enable actuatingconnector 410 to “float,” i.e., move relative to panel 14. In theembodiment shown, valve actuating connector 410 has a cylindrical,tubular connector body 412 defining a fluid passage 414 therethrough.Connector body 412 has an outwardly extending, annular flange 416 formedat the free end thereof. Flange 416 has a downwardly facing annulargroove 418 dimensioned to receive an O-ring 422. Connector body 412includes a threaded portion 412 a. Between flange 416 and threadedportion 412 a is a cylindrical body portion 412 b dimensioned to bereceived within a circular opening 424 within panel 14. The diameter ofopening 424 in panel 14 is larger than the diameter of cylindrical bodyportion 412 b of connector body 412. An annular groove 426 is formedaround opening 424 in panel 14. A threaded collar 432 is provided tosecure connector body 412 to panel 14, as illustrated in FIGS. 12 and13. Collar 432 includes an annular groove 434 formed therein. Groove 434in collar 432 is dimensioned to match annular groove 426 within panel14. A biasing element 442, in the form of a helical spring, is disposedwithin annular grooves 426, 434 formed within panel 14 and threadedcollar 432. Threaded collar 432 is maintained in position on connectorbody 412 by a retaining ring 444 disposed within an annular slot formedwithin connector body 412. The biasing effect of helical spring 442causes flange 416 of tubular connector body 412 to force O-ring 422 intoengagement with the upper surface of panel 14. Valve actuating connector410 is thus free to move a limited amount within cylindrical opening 424in panel 14. Opening 424 is at all times sealed by O-ring 422 that isforced into engagement with panel 14 by the biasing effect of helicalspring 442.

Cap 452 is inserted into a counter-bored opening formed in the free,upper end of connector body 412. Cap 452 is cylindrical in shape andincludes an axially extending pin 454 at the end thereof Openings 456are formed through the end of cap 452 to communicate with fluid passage414 defined by tubular connector body 412. An annular groove 462 isformed within cap 452 to receive O-ring 464. Cap 452 is dimensioned tobe received within opening 302 defined by sleeves on the respectivefluid assemblies 280, 340, 360 wherein O-ring 464 sealingly engagesinner surface 302 of such sleeve. The lower end of connector body 412,shown in FIGS. 12 and 13, is connected to, or forms part of, branchreturn line 106 of fluid circulation system 60, as illustrated in FIG.2. In this respect, two other valve actuating connectors 410 areattached to panel 14 to operatively engage first and second fluid inletassemblies 340, 360, as seen in FIG. 2. Connector body 412 of valveactuating connector 410 that is associated with first fluid inletassembly 340 is connected to, or forms part of, first branch feeder line92. Connector body 412 of valve actuating connector 410 that isassociated with second fluid inlet assembly 360, is connected to, orforms part of, second branch feeder line 94.

Referring now to FIGS. 3, 10 and 11, handle assemblies 510 are providedat the ends of tray 202 are best seen. Each handle assembly 510 includesa handle bracket 512 having a mounting portion 512 a for attachment toside wall 206 of tray 202 by conventional fasteners 514, as illustratedin the drawings. A handle or grip portion 512 b extends from mountingportion 512 a. Coplanar, spaced-apart slots 522, best seen in FIG. 3,are formed along the lateral end of handle portion 512 b to slidablyreceive a generally planar latch element 524. Latch element 524 isdimensioned to slide within slots 522 of handle portion 512 b. Pins orfasteners 528 extend through handle portions 512 b into elongatedopenings 526 in latch 524 to allow a limited portion of latch 524 toslide within handle portion 512 b. Latch 524 includes a bump or dimple532 formed on the upper surface of one end thereof and a tab 534 formedon the bottom surface at the opposite edge of latch 524. Latch 524includes an aperture 536 that is alignable with an aperture 542 inhandle portion 512 b. Latch 524 is provided to lock lid 550 onto tray202.

Lid 550, best seen in FIG. 3, is generally a planar element that isshaped to enclose the opened, upper end of tray 202. Lid 550 includes apair of downwardly extending, generally continuous rails or wallsections 552, 554 that extend along the periphery of lid 550. Wallsections 552, 554 are dimensioned to be disposed in mating contact withrails 212, 214 on the upper edge of side wall 206 of tray 202, as bestseen in FIGS. 10 and 11. As illustrated in FIGS. 10 and 11, wallsections 552, 554 on lid 550 are slightly shorter than rails 212, 214that extend from the upper edge of side wall 206, wherein lid 550essentially rests upon the upper edges of rails 212, 214 of side walls206 of tray 202. A U-shaped gap or space 562 is defined between thedownwardly extending wall sections 552, 554 of lid 550 and rails 212,214 and the upper surface of side wall 206. The interlocking arrangementbetween lid 550 and tray 202 defines a novel type of seal assembly, asshall be described in greater detail below.

Lid 550 includes an extension portion 572 that is dimensioned to overlayhandle assembly 510 on tray 202. A ledge or lip 574 is formed onextension portion 572. Lip or ledge 574 is dimensioned to be disposed ingeneral alignment with handle portion 512 b of handle assembly 510wherein latch element 524 may be moved to a locking position whereinlatch element 524 is disposed over lip or ledge 574 of lid 550. In thisposition, latch element 524 captures ledge 574 between latch element 524and handle assembly 510 thereby locking lid 550 in position onto tray202. Extension portion 572 of lid 550 also includes an aperture 576 thatis positioned to be aligned with apertures 542 within handle portion 512b of handle assembly 510, and aperture 536 in latch element 524 whenlatch element 524 is in a locked or latched position.

In accordance with another aspect of the present invention, a lockingdevice 590 is provided to secure lid 550 to tray 202. Locking device 590is comprised of a body portion 592 and an elongated, flexible armportion 594 that extends therefrom. Arm portion 594 is dimensioned to beable to extend through apertures 576, 536 and 542 in lid 550, latch 524and handle portion 512 b and inserted back into body 592, in a mannersimilar to conventional tie-lock bands. In this respect, body portion592 and elongated arm portion 594 are preferably integrally formed of amoldable plastic material, wherein the end of arm portion 594 may beinserted into an opening in body portion 592, but may not be removedonce inserted therein. Arm portion 594 is preferably dimensioned to berelatively easily broken by movement of latch element 524 away from thelatching position, as shall be described in greater detail below.

Referring now to FIGS. 14-18, an instrument holder 610 for use withincontainer 200 for organizing and positioning items, such as medicalinstruments, for microbial deactivation is best seen. In the embodimentshown, instrument holder 610 is basically comprised of a base section612 (best seen in FIG. 15) and an upper section 652 (best seen in FIG.17). Base section 612 is basically comprised of a wire frame 614 that isformed to support a perforated panel 616 that is disposed at one end offrame 614. Panel 616 is surrounded by a generally U-shaped rail 618.Frame 614 includes two parallel, spaced-apart frame members 622, 624. Anupturned stop 626 is formed at one end of frame 614. Frame 614 includesinstrument holder 630 that is dimensioned to be attached to framemembers 622, 624. Each instrument holder 630 is comprised of aninstrument mounting block 632 and a plate 634 that is attachable toblock 632. As best seen in FIG. 16, block 632 includes cylindricalgrooves 636 formed along the bottom edges thereof, wherein frame members622, 624 of base section 612 may be captured between block 632 and plate634 of instrument holder 630. Conventional fasteners 638 are used toattach plate 634 to mounting block 632 and to secure instrument holder630 to frame members 622, 624, as best seen in FIG. 16.

Mounting blocks 632 are preferably formed of a generally rigid,polymeric material and include a plurality of slots 642 havingpredetermined profiles. Slots 642 are generally defined by a pluralityof aligned, side-by-side, overlapping circular areas 644. Slots 642 havean opened upper end and a closed lower end, and side walls that convergetoward each other from the open end to the closed end. Circular areas644 are preferably designed to receive a plurality of objects of varyingcircular diameter, namely tubular portions of medical instruments, asillustrated in FIG. 16.

Referring now to FIG. 17, upper section 652 is best seen. Upper section652 is basically a wire, rack or tray that is formed to have an annularholding area 654 and a rectangular holding area 656. Upper section 652is designed to nest and mate with lower base section 612, as illustratedin FIG. 14.

Referring now to FIG. 18, a system for deactivating lumens and passageswithin a medical device is illustrated. FIG. 18 shows tray 202 with abronchoscope B positioned within instrument holder 630 (shown inphantom). A flexible connector 712 is attached at one end to connectorfitting 234 in relief or recess 232 of mounting block 222, and the otherend of flexible connector 712 is attached to a fitting on medicalinstrument B. Flexible connector 712 is attached to connector fitting234 on tray 202 to define a microbial deactivation fluid flow path tothe lumens in medical instrument B. Flexible connector 712 includes alength of medical-grade tubing 714 having a male fitting 722 (best seenin FIG. 19) at one end, and a link assembly 810 (best seen in FIGS.20-22) at the other end for attachment to medical instrument B.

Referring now to FIG. 19, male fitting 722 for attaching flexibleconnector 712 to tray 202 is shown. Fitting 722 includes a cylindricalportion 724 for insertion into connector fitting 234 that is attached tomounting block 222. Cylindrical portion 724 includes an O-ring 726mounted within a groove that is formed in cylindrical portion 724 nearthe free end thereof. An annular slot 728 is formed in cylindricalportion 724 above O-ring 726. An internal bore or passage (not shown inthe drawings) is formed through cylindrical portion 724 and male fitting722 to be in communication with the passage defined by tubing 714.

Connector fitting 234 that is attached to mounting block 222 isbasically a female connector having a threaded portion 732 for threadedinsertion into a bore mounting pad 222. Connector fitting 234 has a bodyportion 734 with an opening 736 extending therethrough in fluidcommunication with opening 366 in bottom wall 204 of tray 202. A slot738 is formed through the upper end of connector body 734 to receive alock element 742 in sliding fashion. Lock element 742 has planar portion742 a dimensioned to be received within slots 738 formed in connectorbody 734. A circular opening 744 is formed in planar portion 742 a oflocking element 742. Locking element 742 also includes a thumb portion742 b that is disposed at a right angle to planar portion 742 a oflocking element 742. A biasing element 746, that in the embodiment shownis a helical spring, is disposed between the thumb portion 742 b oflocking element 742 and connector body 734. Biasing element 746 isoperable to bias thumb portion 742 b away from connector body 734.Locking element 742 is maintained in connector body 734 by cap screw 752that extends through a slot 754 in planar portion 742 a of lockingelement 742. As shown in FIG. 19, slot 754 in planar portion 742 a oflocking element 742 communicates with circular opening 744 therein.Locking element 742 is moveable by depressing thumb portion 742 b to afirst position, wherein circular opening 744 in locking element 742 isaligned with bore 736 in connector body 734. With locking element 742 inthis position, cylindrical portion 724 of male fitting 722 is insertedthrough circular opening 744 in locking element 742 into bore 736 inconnector body 734. With cylindrical portion 724 of fitting 722 withinbore 736 of connector body 734, release of thumb portion 742 b causeslocking element 742 to slide into annular slot 728 formed withincylindrical portion 724, thereby locking fitting 722 into connector body734. In the embodiment shown, connector fitting 234 is a fittingmanufactured by Colder Products Company of St. Paul, Minn.

Referring now to FIG. 20, link assembly 810 is best seen. Link assembly810 is provided to attach flexible connector 712 to a fitting 802, bestseen in FIG. 22 on medical instrument B, to be deactivated. Linkassembly 810 includes an elbow fitting 812 having a first end 812 a thatis dimensioned to receive tubing 714. A hose or tube clamp 814 lockstubing 714 onto first end 812 a of elbow fitting 812. A second end 812 bof elbow fitting 812 is attached to a sleeve 822. Sleeve 822 isgenerally cylindrical in shape and has an inwardly extending annularwall 822 a. An outwardly extending annular flange 816 is formed atsecond end 812 b of elbow fitting 812. Flange 816 on elbow fitting 812is captured and maintained against annular wall 822 a of sleeve 822 by aretaining ring 824. Inwardly extending annular wall 822 a of sleeve 822defines an opening 826 that communicates with the opening through elbowfitting 812. The inner edges of annular wall 822 a and the opening ofelbow fitting 812 are preferably champhered, as shown in the drawings.

A cylindrical collar 832 is fixedly attached to the end of sleeve 822.Collar 832 has internal threads 832 a that are dimensioned to matchexternal threads on fitting 802 on medical instrument B. A tubular valveelement 842 is disposed between sleeve 822 and collar 832. Valve element842 defines a passage 842 a therethrough. Valve element 842 has agenerally L-shaped annular wall 844 extending outwardly from themid-section thereof. Annular wall 844 defines an annular recess 846around valve element 842. A biasing element 848, in the form of ahelical spring, is disposed in recess 846 between L-shaped annular wall844 of valve element 842 and inwardly extending annular wall 822 a ofsleeve 822. Biasing element 848 is operable to bias valve element 842away from opening 826 in sleeve 822. A pin 852 embedded within valveelement 842 extends into a slot 854 that is formed along the innersurface of sleeve 822. Pin 852 and slot 854 maintain the position ofvalve element 842 relative to sleeve 822, and guides valve element 842within sleeve 822. Notches or openings 862 are formed in L-shapedannular wall 844 of valve element 842. Notches or openings 862 inL-shaped annular wall 844 are aligned with openings 864 that are formedthrough sleeve 822.

When not attached to a medical instrument, link assembly 810 assumes afirst position, as seen in FIG. 20, wherein valve element 842 is biasedaway from elbow fitting 812 and the passage that is definedtherethrough. In this respect, a portion of any fluid flowing throughflexible connector 712 would flow through passage 842 a in valve element842, but have another portion that would bypass valve element 842 andflow around valve element 842, and flow through notches 862 and openings864 in L-shaped annular wall 844 and sleeve 822, respectively.

When properly attached to fitting 802 of medical instrument B, valveelement 842 assumes a second position, wherein one end of valve element842 is seated against the surface of elbow fitting 812, and the otherend of valve element 842 is seated against fitting 802 on medicalinstrument B. Fluid flowing through flexible connector 712 is thusdirected only through passage 842 a in valve element 842 and into thepassage within fitting 802 on medical instrument B, and thus flowsthrough the lumens and passageways within medical instrument B.

Apparatus 10 shall now further be described with reference to theoperation thereof. One or more items to be deactivated, such as medical,dental, pharmaceutical, veterinary or mortuary instruments or otherdevices are loaded into container 200. Certain items may be placedwithin instrument holder 610, as shown in FIG. 14, while other items maybe set in the bottom of tray 202, resting within surface recesses 242,244, 246 and 248 therein.

In this respect, container 200 can accommodate numerous types of medicalinstruments and other items. Certain medical instruments include lumens,i.e., passages, that extend therethrough. Instruments, such asbronchoscopes and endoscopes, are preferably set into instrument holder610, wherein elongated, flexible tubes on such devices may be placedinto annular holding area 654 of upper section 652, as shown in FIG. 14.Flexible connectors 712 are used to connect fluid passages 366 on tray202 to internal lumens of the medical instruments. More specifically,flexible connectors 712 are dimensioned such that link assemblies 810fit onto fittings on the medical instruments so as to enable microbialdeactivation fluid to be forced through the lumens of the medicalinstruments. The medical instrument would be set within instrumentholder 610 and link assemblies 810 of flexible connectors 712 that wouldbe attached to tray 202 using connector fittings 234, 236. Linkassemblies 810 on flexible connector 712 are then attached to theport(s), i.e., fittings, on the medical device. As shall be described ingreater detail below, a deactivation cycle would not be performed if amale connector assembly is attached to a female connector assemblyunless link assemblies 810 on flexible connector 712 are properlyconnected to the fittings on the medical instruments.

Once flexible connector(s) 712 have been attached to tray 202 and to themedical instrument, lid 550 is placed over tray 202. As best illustratedin FIGS. 8-11, upwardly extending rails 212, 214 of side wall 206 oftray 202 interact with spaced-apart walls 552, 554 on lid 550, as shownin FIGS. 8-10. As indicated in FIGS. 8-10, lid 550 essentially rests onthe upper ends of rails 212, 214 on side wall 206. In this respect, asshown in the drawings, wall members 552, 554 of lid 550 are slightlyshorter than rails 212, 214 on side wall 206 such that generallyU-shaped passage 562, best seen in FIG. 10, extends around container 200between the mating periphery of lid 550 and side wall 206. A convoluted,generally serpentine passage is thus defined between lid 550 and theupper edge of side wall 206. The serpentine passage extends between theinterior of container 200 to the exterior of container 200.

With lid 550 properly positioned upon tray 202, lid 550 is locked intoposition by sliding latch element 524 on handle assembly 510 over ledge574 on lid 550, as best seen in FIG. 10.

In accordance with one aspect of the present invention, once theinstruments or items to be microbially deactivated are placed withintray 202 and lid 550 has been attached and latched thereto, lockingdevice 590 is attached to extension portion 572 of lid 550 and to handleassembly 510, as best seen in FIG. 10, to prevent lid 550 from beingremoved from tray 202. As indicated above, in a preferred embodiment ofthe present invention, locking device 590 is preferably a polymer strapthat is lockable onto itself. With the contaminated instruments withincontainer 200 and locking device 590 attached thereto, container 200 isplaced within deactivation chamber 50. In this respect, first and secondfluid inlet assemblies 340, 360 and outlet fluid assembly 280 arealigned with valve actuating connectors 410 on panel 14 to connectcontainer 200 and the fluid passages therein to first and second branchfeeder lines 92, 94 and branch return line 106 of fluid circulationsystem 60, as schematically illustrated in FIG. 2. Chemical deliverycontainer 34 is then placed in receiving well 32 in apparatus 10. Lid 42of apparatus 10 is then closed and latched thereby sealing deactivationchamber 50.

FIGS. 12 and 13 show how valve actuating connectors 410 on panel 14interact with valve elements 312 of fluid inlet assemblies 340, 360 andfluid outlet assembly 280 to place the interior of container 200 influid communication with the respective branch feeder lines 92, 94 andreturn line 106. More specifically, pin 454 on actuating connector 410pushes valve element 312 on an associated fluid assembly 280, 340, 360to move the same from its sealing position to its opened position. Inother words, once container 200 is set into place and interacts withcorresponding actuating connectors 410, branch inlet lines 92, 94 are influid communication with the interior of container 200, and branchreturn line 106 is in fluid communication with the interior of container200.

The items are microbially deactivated with a microbial deactivationfluid, such as a peracetic acid fluid, which in a preferred embodiment,is formed by exposing and mixing dry chemical reagents within chemicaldelivery container 34 with incoming water. In this respect, at thebeginning of a deactivation operation, drain valve 122 in fluidcirculation system 60 is closed, and valve 72 in water inlet line 62 isopened to allow heated water to enter fluid circulation system 60.Incoming water is first filtered by filter elements 64, 66 that removemacro particles above a certain size, such as 0.1 micron (μ) or above.Filter elements 64, 66 are sized to successively filter out smallersized particles. Incoming water is then treated by UV treatment device68 that applies ultra-violet (UV) radiation to the water to reduce thelevel of viruses therein. The incoming water then passes valve 72 andenters fluid circulation system 60. The incoming water is then filteredby micro filter elements 84, 86 in system feeder line 82, and proceedsto fill fluid circulation system 60, deactivation chamber 50, andcontainer 200. All of the incoming water preferably flows through filterelements 84, 86, thereby insuring filtration of the water flowing intoapparatus 10.

The incoming water is under pressure from an external source, and forcesair in fluid circulation system 60, deactivation chamber 50 andcontainer 200 that is preferably disposed at the highest point ofapparatus 10. As a result of water entering apparatus 10, air within thesystem will migrate toward air inlet/fluid overflow assembly 132.

The presence of the water flowing through air inlet/fluid overflowassembly 132 is indicative that apparatus is filled. The systemcontroller then causes water valve 72 to close, thereby stopping theflow of water into apparatus 10, i.e., into fluid circulation system 60,deactivation chamber 50 and container 200.

The foregoing description basically describes a water fill phase ofapparatus 10.

Once apparatus 10 is filled with water, the system controller initiatesa generation and exposure phase of operation, wherein pump 116 isenergized to circulate water through fluid circulation system 60,deactivation chamber 50 and container 200. Valve 102 in second branchfeeder line 94 is opened to create flow through chemical deliverycontainer 34. The water and dry chemical reagents within chemicaldelivery container 34 form a microbial deactivation fluid that, asindicated above, in a preferred embodiment of the invention, isperacetic acid. The deactivation fluid formed from the dry chemicalreagents flows into fluid circulation system 60, wherein it iscirculated through fluid circulation system 60, deactivation chamber 50and container 200 by the operation of pump 116. As indicated in thedrawings, a portion of the microbial deactivation fluid flows intodeactivation chamber 50 around container 200, and a portion of themicrobial deactivation fluid flows into and through container 200 andthe items contained therein. The microbial deactivation fluid flowingthrough branch feeder line 92 into first fluid inlet assembly 340 isdirected through passages within container 200 to spray nozzles 256,258, as best seen in FIG. 5. The microbial deactivation fluid is thusforced into interior cavity 208 of container 200 to fill the same. Inone embodiment of the present invention, a portion of the microbialdeactivation fluid flowing into first fluid inlet assembly 340 isdirected through passage 354 in side wall 206 into U-shaped gap 562defined between container 200 and lid 550, as best seen in FIG. 4. Inthis respect, a portion of the microbial deactivation fluid flowing intocontainer 200 is directed through tube 352 to the interface between lid550 and tray 202 via passage 354 through side wall 206, as shown in FIG.8. The microbial deactivation fluid flows through U-shaped gap 562between lid 550 and the upper edge of side wall 206 to the opposite sideof tray 202 where it is allowed to enter interior cavity 208 of tray 202through opening 218 defined in innermost rail 212 on side wall 206, asshown in FIG. 9. Basically, microbial deactivation fluid is forced intothe seal region where it flows throughout the seal thereby deactivatingthe convoluted, serpentine passage defined between container 200 and lid550.

The microbial deactivation fluid flowing into second fluid inletassembly 360 is directed to the lumens of the medical instrument throughflexible connector 712, as described above. The microbial deactivationfluid flowing through container 200 is returned to pump 116 via branchfluid return line 106 and system return line 112. Microbial deactivationfluid flowing through deactivation chamber 50 returns to pump 116 viabranch fluid return line 108 and system return line 112. Microbialdeactivation fluid flowing through chemical delivery container 34returns to pump 116 via branch fluid return line 104 and system returnline 112. Pump 116 continuously re-circulates the microbial deactivationfluid through fluid circulation system 60 for a predetermined period oftime that is sufficient to decontaminate items within container 200 andin addition to decontaminate the components and fluid conduits of fluidcirculation system 60.

After a predetermined exposure period, the system controller initiates adrain phase, wherein drain valve 122 is opened and the microbialdeactivation fluid is drained from fluid circulation system 60,deactivation chamber 50 and container 200.

After the microbial deactivation fluid has been drained from apparatus10, one or more rinsing phases are performed to rinse any residualmicrobial deactivation fluid and any residual matter from thedeactivated items within container 200. In this respect, inlet valve 72is opened to introduce fresh water into apparatus 10, in a manner asheretofore described as the fill phase. After each rinse fill, the rinsewater is drained from apparatus 10 as heretofore described. Pump 116 maybe activated to circulate the rinse water through apparatus 10. Duringeach fill, circulation and drain phase, fluid over-flow/air make-upassembly 132 operates to prevent bio-contaminants from entering theinternal environment within apparatus 10.

In the embodiment shown, the circulated deactivation fluid flows throughfilter elements 84, 86. The amount of fluid flowing through therespective portions of the system may be controlled by regulating valvesdisposed within fluid circulation system 60. The microbial deactivationfluid flowing through filter feed line 82 and through filter elements84, 86 are to insure deactivation of filter elements 84, 86 by exposureto the microbial deactivation fluid. In this respect, the flow of thedeactivation fluid through filter elements 84, 86 deactivates the sameand deactivates any bio-contamination that may have entered into filterelements 84, 86 during the water fill cycle. Thus, during each operationof apparatus 10, filter elements 84, 86 are exposed to a deactivationfluid to deactivate same. Bypass line 76, best seen in FIG. 2, controlsthe amount of chemicals flowing through filter elements 84, 86. Asindicated above, the microbial deactivation fluid flows throughout theclosed-loop, fluid circulation system 60 during a deactivation phase,thereby decontaminating fluid circulation system 60, and the componentsand fluid conduits forming the same. In other words, fluid circulationsystem 60 is decontaminated during each decontamination cycle.

Once the deactivation phase has been completed, lid 42 of apparatus 10may be opened and container 200 with the deactivated instruments thereinmay be removed. Fluid assemblies 280, 340 and 360 move to a closedposition when container 200 is removed from apparatus 10, therebypreventing microbial contamination of the interior of container 200.

In accordance with one aspect of the present invention, the deactivatedinstruments can remain in container 200 as a sort of deactivatedpackaging, and may be stored on a shelf for a prolonged period of time,with the instruments therein remaining in a microbially deactivatedenvironment due to the lack of exposure to the surrounding environment.In this respect, the only way for the atmosphere to enter container 200is through the tortuous path defined by rails 212, 214 and wall sections552, 554 of tray 202 and lid 550, respectively. In this respect, it hasbeen found that such a design prevents migration of bacteria ororganisms along the serpentine, U-shaped gap 562 due to the microbiallydeactivated conditions therein.

Still further, it is believed that notwithstanding an air blow off phaseto force fluid from container 200, that the interior of container 200will remain somewhat “damp” therein. The damp interior of container 200may be dried in a low heat oven, wherein the moisture would be drivenfrom the interior of container 200 over time. Locking devices 590 on lid550 and tray 202 provide an indication that the instruments therein aremicrobially deactivated when locking devices 590 are intact, indicatingthat container 200 has not been opened.

When a microbially deactivated instrument is needed for use, lid 550 maybe removed by simply sliding latching element 524 away from its lockingposition.

Referring now to FIG. 23, a block diagram illustrating a monitoringsystem 910 for ensuring proper connection of link assemblies 810 tofittings 802 on medical instrument B is shown. Monitoring system 910 isgenerally comprised of a pressure sensor 912, a controller 914, an alarm916, a display unit 918, and an input unit 922.

Pressure sensor 912 measures the pressure of the microbial deactivationfluid flowing through second fluid inlet assembly 360 to flexibleconnector(s) 712. Pressure sensor 912 outputs an electrical signalindicative of a sensed fluid pressure value. This electrical signal isreceived by controller 914, as described below. In a preferredembodiment, pressure sensor 912 takes the form of a pressure transducer.

Controller 914 is preferably the system microprocessor ormicrocontroller used to control other system operations and components.Controller 914 is programmed to determine whether each flowable linkassembly 810 on flexible connector 712 has been properly connectedwithin container 200, based upon the electrical signal indicative of thesensed fluid pressure value, as will be described in further detailbelow. An alarm 916, that preferably takes the form of an audiogenerating means (e.g., a speaker) for generating an audible signal, isprovided to alert the operator to an error condition, namely, theimproper connection of the tubing.

A display unit 918 provides a means for visually communicating with anoperator. In a preferred embodiment, display unit 918 takes the form ofan LCD or LED display.

Input unit 922 provides a means for the operator to enter data intocontroller 914. In a preferred embodiment, input unit 922 takes the formof a conventional keypad or keyboard.

Operation of monitoring system 910 shall now be described in detail. Asindicated above, pressure sensor 912 measures the pressure of themicrobial deactivation fluid flowing through second fluid inlet assembly360 to flexible connector 712. Pressure sensor 912 outputs an electricalsignal indicative of a sensed fluid pressure value that is received bycontroller 914. Controller 914 is programmed to determine whether thesensed fluid pressure value (received from pressure sensor 912) isindicative of a predetermined pressure value associated with properconnection of a flowable link assembly 810 on flexible connector 712 tofitting 802 on medical instrument B. For instance, controller 914 maycompare the sensed fluid pressure value to the predetermined pressurevalue. If the comparison indicates a significant deviation from thepredetermined pressure value, controller 914 determines that an improperconnection to medical instrument B exists in container 200. An improperconnection may be the result of a link assembly 810 not being properlyconnected to a fitting 802 on a medical instrument. FIG. 22 shows a linkassembly 810 that is properly connected to a matching fitting 802 on amedical instrument (not shown in FIG. 22). When link assembly 810 isconnected to the medical device as shown, valve element 842 is snugglyseated against elbow fitting 812 and fitting 802. All of the microbialdeactivation fluid flowing through flexible connector 712 is forced intothe lumens of the medical device and would establish the predeterminedpressure value.

If link assembly 810 is not securely connected to fitting 802, or iflink assembly 810 does not match fitting 802 on the medical instrument,valve element 842 will not be properly seated against elbow fitting 812or fitting 802, thereby allowing fluid to flow around valve element 842through opening 864 in sleeve 822 or between fitting 802 and sleeve 822.This condition would result in a pressure lower than the predeterminedpressure value being sensed by pressure sensor 912, the lower pressurebeing an indication of a faulty connection between flowable flexibleconnector 712 and the medical instrument. Likewise, if the systemcontroller determines that a connection is to be made, a lower thanexpected pressure may be an indication that male fitting 722 on flexibleconnector 712 is not properly attached to connector fitting 234 or 236on tray 202.

Furthermore, the improper connection may be the result of only one oftwo flowable flexible connectors 712 being attached to a medicalinstrument, when two flexible connectors 712 must be connected to twoports on one or more medical devices. It should be appreciated that alower pressure will be sensed when there is an improper flowableconnection.

In a preferred embodiment, detection of an improper connection resultsin controller 914 activating alarm 916 to produce an audible warningsignal to the operator, and controlling display unit 918 to: (a) displaya graphic indicating the location within apparatus 10, and specificallycontainer 200, where an improper connection has been detected, and (2)provide visual and/or written instructions as to how to correct theimproper connection. The operator may also be queried as to whether hewishes to proceed with a deactivation cycle, or abort the currentdeactivation cycle.

It should be appreciated that more than one pressure sensor 912 may beused. In this regard, pressure sensor 912 may be associated with eachflexible connector 712.

The foregoing description is a specific embodiment of the presentinvention. It should be appreciated that this embodiment is describedfor purposes of illustration only, and that numerous alterations andmodifications may be practiced by those skilled in the art withoutdeparting from the spirit and scope of the invention. Specifically,although the present invention has been described with respect to areprocessor utilizing a microbial deactivation fluid, it is contemplatedthat the present invention be used in reprocessing systems wherein a gasor vapor microbial deactivation fluid is used. It is intended that allsuch modifications and alterations be included insofar as they comewithin the scope of the invention as claimed or the equivalents thereof.

1. A method of microbially deactivating items and storing the same in asealable container forming a microbial barrier completely enclosing saiditems, comprising the steps of: a) placing items within a cavity in asealable container having fluid access ports therein, said fluid accessports having a normally closed position and being moveable to an openposition; b) placing said container having items to be microbiallydeactivated in said cavity into a reprocessor having a circulationsystem for circulating a microbial deactivation fluid during adeactivation cycle; c) causing said fluid access ports in said containerto engage actuating means on said reprocessor wherein engagement of saidfluid access ports with said actuating means moves said fluid accessports to said open position to be in fluid communication with saidcirculation system; d) circulating said microbial deactivation fluidthrough said cavity of said container; and e) removing said containerfrom said reprocessor following a deactivation cycle; f) disengagingsaid fluid access ports from said actuating means on said reprocessorduring said step e) of removing thereby causing said fluid access portsto assume said normally closed position sealing said container, saidsealed container forming a microbial barrier completely enclosing saiditems; g) storing said sealed container with said items therein at alocation remote from said reprocessor for a period of time whilesimultaneously maintaining said microbial barrier completely enclosingsaid items therein.
 2. A method as defined in claim 1, furthercomprising the step of: h) placing said container in a heated chamber todry off moisture in said container while maintaining said items in adeactivated state.
 3. A method of microbially deactivating items andstoring the same in a sealable container forming a microbial barrieraround said items, comprising the steps of: a) placing items to bedeactivated into a cavity in a sealable container having a controllablefluid access port, said fluid access port being moveable between anormally closed position and an open position; b) placing said containerhaving items to be deactivated therein into a reprocessor having acirculation system for circulating a microbial deactivation fluidthrough said cavity; c) causing said fluid access port to move to saidopen position from said normally closed position by contacting actuatingmeans on said reprocessor as said container is placed into saidreprocessor; d) circulating said microbial deactivation fluid throughsaid cavity; e) removing said container following a deactivation cycle;f) causing said fluid access port to move to said normally closedposition when said fluid access port no longer contacts said actuatingmeans sealing said container, said sealed container forming a microbialbarrier completely enclosing said items; and g) storing said sealedcontainer with said deactivated items therein while simultaneouslymaintaining said microbial barrier completely enclosing said itemstherein.
 4. A method as defined in claim 3, wherein said microbialdeactivation fluid is a liquid solution.
 5. A method as defined in claim4, further comprising the step of: h) heating items within saidcontainer to evaporate moisture from said items while maintaining saiditems in a deactivated state.